JP2019030701A - Pressure cuff or garment - Google Patents

Abstract

To provide a pressure cuff or a garment suitable for deep vein thrombosis prophylaxis.SOLUTION: A pressure cuff or a garment 10 includes a first or distal chamber 24, a second or mid chamber 26 and a third or proximal chamber 28, which are inflatable, arranged in series and coupled in fluid communication with each other by a first bleed tube or choke 32 or a second bleed tube or choke 34. The inflatable chambers 24, 26, 28 are of curved shapes to overlap with one another.SELECTED DRAWING: Figure 4

Description

  The present invention relates to a pressure cuff or garment particularly suitable for preventing deep vein thrombosis.

  One important accepted principle of deep vein thrombosis (hereinafter referred to as DVT) prevention is to perform intermittent compression on the patient's extremities, particularly the legs where DVT occurs most frequently. The purpose of such intermittent compression is to prevent stasis that can cause thrombus formation. In particular, the procedure temporarily occludes the patient's blood vessel by compressing the vein, and then opening the blood vessel by releasing the compression pressure, allowing blood to flow into the vein all at once, avoiding prolonged congestion. Thus, there are generally two different stages in the applied DVT treatment profile. There is a first inflation period in which pressure is applied to the patient's anatomy, followed by a second (waiting) period in which this pressure is reduced or removed and blood flow resumes in the vein. This cycle is then repeated to maintain an increase in the patient's blood flow velocity and thus prevent venous congestion.

  In order to extract the maximum performance of the garment, it is important to obtain the maximum clinical effect during the first period when pressure is applied and to maximize the clinical effect during the second period. These two periods require various utilities and features to optimize the overall treatment applied and the resulting clinical effect.

  Applicant's earlier US Patent Application Publication No. 2005 / 070,828 discloses a garment designed to provide continuous DVT prophylaxis treatment through the inlet of one tube. The garment includes a plurality of inflatable and retractable chambers that are contracted by a bleed valve or drain valve to maintain accurate pressure in the intermediate and proximal chambers. However, the bleed valve, in some situations, gives the impression that the garment is leaking, causing the user's anxiety and the risk of ineffective use. The device of this earlier application requires control of the following variables: individual chamber volumes; interconnected bleed tube dimensions; and mushroom bleed grommet dimensions.

  Known devices also include a matched inflation chamber separated by a separation wall that provides a given longitudinal direction to separate a patient's limb or body part into separate zones for treatment. It arrange | positions over position.

  The present invention aims to provide an improved garment or cuff for the treatment of patients, in particular for the prevention of deep vein thrombosis.

  According to one aspect of the present invention, an inflatable garment is provided for application to a patient, the garment having a tubular or partially tubular form used in the longitudinal dimension and by a first separating wall to each other. An inflator having first and second inflatable chambers separated and arranged side by side so that the first separation wall extends to different longitudinal positions around the tubular form of the garment. And the first and second chambers overlap longitudinally when the garment has the tubular or partially tubular configuration.

  This structure provides a multi-chamber inflatable device that can be inflated in a known manner, where the patient does not have the effect of pressure treatment, such as dead areas that can occur with known devices. There is a longitudinal overlap between adjacent chambers so that they do not remain in the body. It can be said that the separating walls do not extend into a common longitudinal plane during use, unlike prior art structures.

  The separating wall preferably has a curved shape even when the garment is in a flat state.

  In a preferred embodiment, the garment comprises at least one third chamber arranged side by side with the second chamber, the second and third chambers being separated from each other by a second separation wall, The separating wall is curved to extend to different longitudinal positions around the tubular form of the garment, and the second and third chambers are longitudinally when the garment has the tubular or partially tubular form. Duplicate.

  Advantageously, the first wall and the second wall have different curvatures. The second separation wall can have a greater curvature than the first separation wall, thereby increasing the second chamber and the third greater than the overlap between the first chamber and the second chamber. Overlap with the chamber is obtained.

  In one practical embodiment, the first chamber has a curved wall on the opposite side of the first separation wall. The third chamber can have a curved wall on the opposite side of the second separation wall. Advantageously, the expansion device has rounded or curved edges. The edge is preferably the edge of the expansion chamber. Such rounding improves the suitability and comfort of the device to the patient.

  Preferably, a choke is provided connecting adjacent chambers to each other, each particular or each choke having a predetermined dimension. A particular or each choke can be in the form of a connecting tube. The inflator has a plurality of chokes, which preferably have the same predetermined dimensions. In another embodiment, the one or more chokes are sized to vary the chamber expansion and contraction rates.

  A particular or each choke can have a length of about 40 mm and an bore diameter of about 0.8 mm.

  The inflatable garment preferably has at least three chambers arranged in series.

  In some implementations, the first chamber is preferably larger than the second and other chambers. For example, the second chamber can be about 70% of the size of the first chamber; the particular or third chamber can be about 55% of the size of the first chamber.

  The garment can comprise a contact member comprising a knitted or woven layer.

  The garment can be a cuff, sleeve, or other garment that is formed or conformable to fit around a portion of the patient's anatomy. It should be understood that the term garment is to be interpreted in its broadest form, including pads or other elements that can be placed on a part of the patient's body.

  In accordance with another aspect of the present invention, an inflatable garment is provided for application to a patient, the garment having first and second inflatable chambers, the first chamber having an inlet and an outlet, The second chamber has a choke that connects the first chamber to the second chamber, and the second chamber is sealed except for the choke.

  Preferably, at least one intermediate chamber disposed between the first chamber and the second chamber is provided, the choke extending from the first chamber to the intermediate chamber or the first intermediate chamber, and A choke extending from the intermediate chamber or the last intermediate chamber to the second chamber is provided, and a particular or each of the intermediate chambers is sealed except for the choke.

  One or more intermediate chambers are preferably permanently sealed except for the choke, and in the case of the first chamber, the inlet, the outlet, and all chokes connected to the first chamber. Sealed except for. Thus, the second and all intermediate chambers are also filled and discharged via the choke without providing a separate exhaust pipe.

  A vent connected to the atmosphere can be provided in the third or intermediate chamber. This vent may be a chamber or choke tube hole.

  The structure is such that an inflation fluid can be supplied to the first chamber, which fluid not only inflates the first chamber, but also the second chamber and all third chambers. Can also be inflated. It is not preferred that the second and third or intermediate chambers are not expanded by other sources except the choke.

  The chambers are preferably spaced from one another so that integral projections of the chamber edges are formed. The perimeter is advantageously a series of curves rather than a uniform shape. Thus, there is a peripheral region located around the leg with an intermediate chamber and a distal chamber applied to different regions. At a distance measured from the distal end of the garment, each chamber has a variable value that depends on the circumferential position considered.

  In a preferred embodiment, the most distal chamber has the largest volume, the next (intermediate) chamber is smaller than the distal chamber, and the most proximal chamber is even smaller. The chamber dimensions are generally as follows: the second or intermediate chamber is about 70% of the size of the first or distal chamber, and the third chamber is about the size of the first or distal chamber. 55%. The expansion volumes of the individual chambers are approximately the same relative ratio.

  It should be understood that the garment is typically formed from a flexible material and is therefore adaptable to the patient's shape.

  It should be understood that various features of the various embodiments and aspects disclosed herein can be combined with each other and the features are not limited to a single embodiment.

  Embodiments of the present invention will now be described by way of example only with reference to the accompanying drawings.

FIG. 1 is a graph of a typical pressure duty cycle for prophylactic treatment of deep vein thrombosis. FIG. 2 is an external view of an example garment designed to be attached to a patient's calf. FIG. 3 is an interior view of an example garment designed to be attached to a patient's calf. FIG. 4 is a schematic view of a preferred embodiment of a calf garment designed to be attached to a patient's calf. FIG. 5 shows the garment of FIG. 4 showing further features of the garment. FIG. 6 is a comparative graph showing the pressure profile of the garment of FIGS. 2-5 compared to a garment formed in accordance with the teachings of US Patent Application Publication No. 2005 / 070,828. FIG. 7 is a comparative graph showing the pressure profile of the garment of FIGS. 2-5 compared to a garment formed in accordance with the teachings of US Patent Application Publication No. 2005 / 070,828. FIG. 8 is a comparative graph showing further details of the pressure profile of the garment of FIGS. 2-5 as compared to a garment formed in accordance with the teachings of US Patent Application Publication No. 2005 / 070,828. FIG. 9 is a comparative graph showing further details of the pressure profile of the garment of FIGS. 2-5 compared to a garment formed in accordance with the teachings of US Patent Application Publication No. 2005 / 070,828. FIG. 10 is an exploded view of one embodiment of a spacer layer of a garment of the type disclosed herein.

  In the embodiments disclosed below, the described garment is designed to be worn around a patient's calf. However, it should be understood that the garment may have various shapes designed to fit around various portions of the patient's anatomy. Typically, the garment is designed to fit around part or all of the patient's leg, but can also be designed to fit around the patient's arm or other body part. To this end, the garment embodiments described below have three inflatable chambers, but different numbers mainly determined by the overall dimensions of the garment, the size of the chamber, and the pressure profile that occurs across the garment. You may have the following chambers. Thus, in some cases, a garment may have only two chambers, and in other embodiments, a garment may have four or more chambers, such as four or five or more chambers. .

  As part of an integrated DVT prevention system, the garment becomes the physical therapeutic delivery interface between the system and the patient. The principle of operation of the garment described below is to apply sufficient contact pressure to the calf or calf and thigh area of the patient's leg to temporarily occlude the deep veins inside the calf, and thus the period during which pressure is applied, Stop the veins that return to the heart. After a predetermined period, typically about 12 seconds after the start of inflation, the garment pressure is released to allow recirculation of venous blood. After a waiting period of about 48 seconds, the 12 second inflation cycle is repeated to again occlude the vein. This cycle is repeated as long as the garment is attached to the patient's calf and the pump is running. An image of this example of a treatment cycle is shown in FIG. This is the duty cycle of the distal chamber of the garment, from which pressure generated in the intermediate and proximal chambers is transmitted, as will be explained below.

  Referring now to FIGS. 2 and 3, FIGS. 2 and 3 show views of the outer surface 12 and inner surface 14 of an embodiment of the garment 10, respectively. The garment is in the form of a calf cuff 10. The garment 10 is formed from a compatible and flexible impermeable polymeric material consisting of two or multiple layers, such as polyvinyl chloride (PVC) or polyurethane / olefin membrane. Various suitable materials will be known to those skilled in the art. This multi-layer body is sealed together in this embodiment to form three chambers interconnected by chokes as described in detail below.

  The garment 10 also includes a plurality of fixation tabs 16, in this embodiment three fixation tabs 16 that are used to secure the cuff 10 in place around the patient's calf. For this purpose, the tab 16 may comprise an adhesive, hook and / or eye fixture, such as Velcro ™ or other suitable fastener. It should be understood that the hooks and / or eye fasteners can cooperate with a suitable receiving material that can be the fabric of the garment 10 cover.

  As can be seen from FIGS. 2 and 3, the cuff 10 can be spread flat and, in use, can surround the patient's calf or lower leg in the form of a sleeve.

  It should be understood that the shape of the garment can be designed for a particular part of the patient's anatomy and thus can be different from the example shown in the drawings.

  FIG. 4 shows in detail the structure of the cuff 10, in particular the inflatable chamber of the cuff. The cuff 10 has an outer edge 20 in which multiple layers of the cuff 10 are typically joined together, but this is not necessary. The multilayer body of the cuff 10 is joined along a line, which in this embodiment is a first or distal chamber 24, at least one second or intermediate chamber 26, and a third or proximal chamber. A three-chamber bag 22 formed from 28 is defined.

  The chambers 24-28 are arranged in fluid communication in series, and for this fluid communication, the distal chamber 24 includes an inlet / outlet port or tube 30 and a first bleed tube inserted into the intermediate chamber 26 or A choke 32 is provided. A second bleed tube or choke 34 connects the intermediate chamber 26 to the proximal chamber 28. With the exception of bleed tubes 32 and 34, the intermediate chamber is completely sealed, ie there are no other ports or valves. The distal chamber 28 preferably has a vent connected to the atmosphere (not shown in the drawing, but can be similar to the chokes 32 and 34). A vent connected to the atmosphere can help achieve the correct pressure for treatment. Such venting can be accomplished by a vent hole laser drilled directly into the chamber wall of the third or proximal chamber, or a choke tube connected to the atmosphere in the third chamber.

  Thus, in the illustrated embodiment, air sent to the inlet 30 enters the distal chamber 24 and then passes through the intermediate chamber 26 via the first bleed tube 32 and from the intermediate chamber 26 to the second Proximal chamber 28 is reached via bleed tube 34. The fluid is drained from the chamber sequentially in a similar manner, but in a direction opposite to the direction through the chamber and bleed tube.

  In the illustrated embodiment, the bleed tube has the same dimensions, preferably 40 mm length, 0.8 mm inner diameter or caliber. In another embodiment, the first bleed tube 32 between the distal chamber 24 and the intermediate chamber 26 is 80 mm long and has an inner bore diameter of 0.8 mm; The second bleed tube 34 between the chambers 28 is 20 mm long and has an inner bore diameter of 0.5 mm.

  These structures of bleed tubes 32 and 34 allow the velocity of fluid to flow from one chamber to the next, and hence the rate of increase of the pressure in the series of chambers, resulting in the rate of change of pressure, as well as chambers 24- It is designed to control the total pressure generated by 28. The vent of the distal chamber 28 ensures that a pressure gradient between the chambers during garment use is maintained. This is described in further detail below.

  Refer now to FIG. FIG. 5 is a schematic view of the bag or cuff 10 of FIG. 4 showing a number of other features of the preferred embodiment construction.

  More specifically, further improvements in the performance of the garment 10 can be achieved by the shape of the chambers 24-28, particularly the chambers overlapping within the garment 10. The chambers 24-26 are designed to overlap longitudinally when worn on the patient's leg. Prior art cuffs use a distinct interface for each of the inflatable chambers of the garment, and an easily recognizable separation is provided between each chamber. As a result, around the patient's leg, the periphery of the chamber forms a uniform shape with distinctly different chamber zones. At a distance measured from the distal end of the garment, which can be expressed as the length or longitudinal extent of the cuff 10, each chamber has a distinct pressure value regardless of the circumferential position considered.

  In the structure of the illustrated embodiment, as shown in detail in FIGS. 4 and 5, the chambers 24-28 are spaced apart from each other to form an integral protrusion. The perimeter is not a uniform shape but a series of curves. Thus, there is a peripheral region located around the leg with an intermediate chamber and a distal chamber applied to different regions. At a distance measured from the distal end of the garment, each chamber has a variable value that depends on the circumferential and longitudinal positions considered.

  In the preferred embodiment, the most distal chamber 24 has the largest volume, the next (intermediate) chamber 26 is smaller than the distal chamber 24, and the most proximal chamber 28 is even smaller. The chamber dimensions are generally as follows: the intermediate chamber 26 is about 70% of the size of the distal chamber 24 and the proximal chamber 28 is about 55% of the size of the distal chamber 24. The expansion volumes of the individual chambers are approximately the same relative ratio. The size relationship of the individual chambers 24-28 is based on the shape of the patient's leg, and the resulting chamber pressure depends on the structure and the selected treatment pressure controlled by the pump.

  Depending on the chamber design, it is possible to achieve higher intermediate chamber pressures than in the prior art.

  The effect of integrating or overlapping chambers 24-28 has additional advantages in terms of comfort, fit, orientation, performance, and efficiency.

For comfort and fit The design of the individual chambers 24-28 avoids the use of straight edges to improve comfort when the garment 10 is inflated. This reduces the apparent differences perceived by the patient between the individual inflatable chambers 24-28. This is particularly advantageous because there are different pressures in the various chambers. The prior art has linear boundaries between the individual chambers.

  Further use of chambers 24-26 having a continuous curve outside the chamber edges integrates the interface between the chamber area and the patient's leg. This reduces the apparent difference perceived by the patient between the inflatable multi-chamber region and the uninflated region of the garment. In the prior art, since the chamber has an orthogonal shape, there is a linear boundary between the multi-chamber region and the remaining region of the garment.

  At the outer periphery of a multi-chamber configuration, there are a number of curved regions that become different 3D forms when inflated compared to the use of linear boundaries. The prior art has many orthogonal shapes with no space between these regions. Thus, patients with more tissue in the leg than others (eg, fatty obese patients) both during initial garment wear and during continuous treatment to prevent overtightening There is an area in the garment where the tissue can enter.

  By using a curved chamber shape at the proximal edge of the multi-chamber garment, compatibility with the upper leg / thigh and / or lower leg / ankle is improved.

Orientation Features The centerline of the cuff 10 is a line for aligning the chambers 24-28 with the center of the back of the leg in the calf region. With this centerline, maximum compression of the flexible tissue can be achieved. Because the cuff has a well-defined shape, it is easy to first align the cuff and to constantly check that the nursing staff always keeps the garment 10 aligned correctly. This can be in addition to the marks provided on the outer surface 14 of the garment 10 for this purpose.

Improved Performance Preferred embodiments of the cuff 10 also have improved performance due to increased pneumatic efficiency. In particular, the preferred design provides a structure with excellent pneumatic efficiency. The sandwiched arrangement of the chambers 24-28 results in a dense multi-chamber configuration that reduces the patient's surface area that is not compressed when placed in the space between the individual chamber regions.

  The force initially applied by the expanding chambers 24-26 occurs in this central region since the central region of the chamber shape can be expanded most. This area matches the central area of the patient's calf where the most tissue is present, and thus can provide improved compression therapy.

  In order to improve the user experience and consequently improve the fit, the pressure in the intermediate chamber 26 and the proximal chamber 26 is maintained by the bleed tubes 32 and 34. The bleed tubes 32 and 34 are designed to reduce the transmitted pressure during the treatment period and to reverse the air at the end of the part to be treated through the garment 10 and the pump.

  In use, the embodiment of the DVT preventive garment 10 described herein may include three chambers 24-28 (three may be as described above, but only two or more chambers may be used). Designed to create a continuous pressure gradient (from distal to proximal) through a two-layer bag or cuff 10 containing The air pressure of the garment 10 can be supplied to the cuff distal chamber 24 via the cuff inlet / outlet tube 30 by a standard DVT pump. Typically, a pressure of 45 mm Hg can be applied. The pressure in the intermediate chamber 26 and the proximal chamber 28 is transferred from this pump pressure. The air pressure for the intermediate chamber 26 and the proximal chamber 28 is controlled by interconnecting tubes 32 and 34, which are designed to “choke” air into the subsequent chambers 26, 28. . The pressure drop from one chamber to the next caused by “choke” depends on the length of the tubes 32, 34 and the bore diameter. In one example, a central bag pressure of 35 mmHg and a proximal bag pressure of 25 mmHg are achieved. This solution can be equally applied to calf garments or calf and thigh garments, with the length and inner diameter of the tube being changed to match the total volume of the garment.

  In the configuration taught, it is not always necessary to vent air to the atmosphere (in the garment) in order to control the bag pressure, but one in the last chamber of the last consecutive chamber counting from the inlet of pressurized air. It is desirable to provide two vents.

  When the pressure rise and hold period (eg, 12 seconds) ends, the bag or cuff 10 is deflated. The pump is configured to wait for a rest period, eg, 48 seconds, from contracting to the next treatment cycle. This contraction allows the venous blood flow to resume and the garment 10 can be prepared for a subsequent treatment cycle. During this contraction and retention period, the pressure of each of the three chambers 24-28 passes from the proximal chamber through the intermediate chamber 26 and the distal chamber 28 via the “choke” tubes 32, 34 and into the inlet / outlet. It is returned to the atmosphere in the reverse direction via the tube 10 and a rotary valve (if present) inside the pump.

  In the structure taught, there are two main independent variables within the scope of the design: (a) individual chamber volumes, and (b) interconnect bleed tube dimensions. By reducing the number of independent variables, the reproducibility of the manufacturing process is improved, thus reducing the risk of errors caused by mass production.

  By removing additional bleed valves from the structure: (a) reduced garment manufacturing costs; (b) improved garment surface without physical bulge of bleed valves; and (c) to atmosphere at bleed valves. Numerous improvements are seen, including removal of noise associated with multiple vents.

  The test calf garment 10 was connected to a Flowtron pump (513003) and operated for a long time to confirm the reproducibility and accuracy of treatment delivery. FIG. 6 shows the pressure profile of the garment 10 measured at the garment inlet tube 30, the intermediate chamber 26, and the proximal chamber 28 through a bleed grommet provided only for testing in the test garment. FIG. 7 shows the pressure profile of a garment formed in accordance with the teachings of US Patent Application Publication No. 2005 / 070,828.

  As explained above, in order to obtain maximum performance, the garment 10 has the greatest clinical effect during the first period during which pressure is applied and also maximizes the clinical effect during the second rest period. . These two periods require various utilities and features to optimize the overall treatment given and the resulting clinical effect. Garment 10 accomplishes this by using a combination of improved expansion characteristics and improved shrinkage characteristics.

  The inflated part of the full cycle consists of different parts: ramp (raising), holding and venting.

  The comparison between FIG. 6 and FIG. 7 shows different initial expansion ramps when comparing the cuff 10 and the prior art. In prior art devices, there is a delay of more than 2 seconds discernable in the ramp period when comparing the onset of expansion of the distal chamber 24 with the other two chambers 26,28. The cuff 10 taught herein does not exhibit this initial delay and can maintain a differential pressure gradient between the individual chambers 24-28 as pressure increases during the ramp and hold periods. Also, in the corresponding points in the ramp portion and holding portion shown in FIGS. 6 and 7, the preferred cuff 10 shown in FIG. 6 has a higher intermediate chamber than the prior art shown in FIG. It can be seen that pressure can be realized.

  As a result of both the reduced delay and the high intermediate chamber 26 pressure, the cuff 10 can apply a stronger compressive force over a longer period of time during the cycle. This ensures that higher pressures exist longer in the various chambers 24-28 of the cuff 10 as compared to prior art structures and still maintain continuity of expansion and contraction. This is similar to the principle that the applied force is equal in the area under the curve.

  The physical shape of the individual chambers 24-28 and the spatial relationship of the individual chambers 24-28 are also added to this effect and will be described in detail below.

  In FIG. 6, it can also be seen that the cuff 10 exhibits a slow contraction of the proximal chamber 28 and the intermediate chamber 26 compared to the prior art, as can be seen with reference to FIG. This is shown in detail in FIG. 8 (cuff 10) and FIG. 9 (prior art). This slow contraction extends the application of pressure even if the distal chamber 24 begins to contract. This is because all the air flow must return to the pump via tubes 30-34 and there is no discharge to the atmosphere. The air pressure in the proximal chamber 28 cannot be reduced until the pressure in the intermediate chamber 26 is reduced, and the air pressure in the intermediate chamber 26 cannot be reduced until the pressure in the distal chamber 24 is reduced.

  Having a series connection to the chamber creates a pressure profile associated with the series. Thus, the intermediate chamber 26 and the proximal chamber 28 have a slow pressure drop over time, and thus the pressure lasts longer than in the prior art.

  Although the pressure level is lower than the pressure level during the holding portion of the contraction period, this pressure level is present and can be considered to be approximately equivalent to the pressure caused by a permanent compression force (eg compression stockings). . This provides further advantages regarding the performance of the garment 10 that did not previously exist in the art.

  Thus, the pressure versus time profile of the contraction portion of the cycle can also have the same compression effect portion that can be provided by a stretchable compression sock. This results in an intermittent compression garment, which also has the additional performance characteristics typically found only in compression stockings, but without the clinical problems associated with constant compression of the limb.

  The resulting effect increases the duration of compression. This is illustrated in FIGS. 6 and 8, where the actual air source is 8 mmHg for about 18 seconds for a cycle time of 60 seconds, even though only 12 seconds of the cycle time of 60 seconds are supplied. There is pressure above the ankle / proximal. Therefore, even if the air pressure from the air source is stopped, there is a residual compressive force on the lower leg / ankle. This further enhances the existing therapeutic effects associated with the intermittent compression cycle.

  As a result of this time differential shrinkage characteristic of each chamber 24-28 pressure versus time and prolonged low residual pressure, the preferred structure of the garment 10 has a more lasting effect on blood flow promotion.

  Also, in patients with impaired venous valve function, eg, patients suffering from superficial venous regurgitation, this improved performance can provide a unique but significant advantage, ie, blood regurgitation. Can help prevent. Thus, the effectiveness of the IPC system can be improved in this type of patient.

  The chambers are preferably arranged in fluid communication in series, similar to the embodiments described below, but in other embodiments the chambers can be arranged in parallel, thereby providing different pressures. A profile is obtained. Similarly, in sequence, it is possible to provide two or more chambers that are actually coupled directly to the first chamber or the previous chamber at the same longitudinal position of the garment, these chambers being at different angular positions of the garment. Have the same or different chokes to obtain different pressure profiles on the sides.

  Reference is now made to FIG. 10, which illustrates one embodiment of a spacer layer that is particularly suitable for DVT garments of the type contemplated herein. This spacer layer can be placed on the patient contact side of the garment and thus directly contacts the patient. Such a spacer layer aims to improve breathability and provide comfort to the DVT preventive garment. Improved insulation, compressive strength, durability, recyclability, pressure redistribution, and high water vapor transmission rate (MVTR) can also be achieved.

  In particular, the known DVT garments are manufactured using three or four layers of material: two layers for the inner bag, i.e. the element to be treated, the outer two layers are the aesthetic and attachment areas of the garment It becomes. Some garments use a fired laminate material as the skin contact material. Polyurethane foam gives cushion comfort. However, the polyurethane foam must be laminated using either an adhesive or a flame fusion process, and both the adhesive and the flame fusion process plug at least some of the cellular pores in the polyurethane foam, It tends to reduce its breathability. Polyurethane foam is also susceptible to UV light and typically changes color. Furthermore, the lamination process increases costs and the garment cannot be recycled.

  Referring now to FIG. 10, this figure shows one embodiment of a spacer layer, which comprises a gas-liquid permeable contact layer 52, a three-dimensional knitted or woven layer 54, and a support layer 56, and includes a bag. It can be one of the layers. The support layer 56 may be gas-liquid permeable when provided as an independent layer of garment. The three-dimensional knitted or woven layer 54 forms a space between the layers 52 and 56 that allows the collection of water vapor and air that has passed through the contact layer 52 and passes through the gaps between the fibers of the layer 54. A gas-liquid passageway extending therethrough can also be defined and considered to form a channel through the layer 54. This space also provides insulation.

  Layer 54 can be formed in a single knitting or weaving process so that the advantages of firing or woven laminates can be achieved without additional processes associated with prior art structures. The strength imparted by the fibers in the 3D structure of layer 54 provides compressive strength, which provides cushioning, comfort, and pressure redistribution in the garment. The fabric structure of layer 54 provides durability by the structure and the yarn used. In contrast, the foam used in prior art laminates is a weak material and reduces the overall strength of the device.

The knitted or woven layer 54 allows a water vapor transmission rate of 35 g / m ² or more per 24 hours, which is significantly higher than some prior art garments.

  The disclosures of British Patent Application No. 121946.5, from which this application claims priority, and the abstract attached to this application are incorporated herein by reference.

Claims (17)

Side-by-side arrangement in an inflatable garment applied to a patient for deep vein thrombus prevention, having a tubular or partial tubular form used in the longitudinal dimension and separated from each other by a first separation wall An inflator comprising first and second inflatable chambers, wherein the first separation wall is curved to extend to different longitudinal positions around the tubular form of the garment; The first and second chambers overlap in the longitudinal direction when the garment has the tubular or partially tubular configuration, and the inflatable garment is further arranged side by side with the second chamber. Two third chambers, wherein the second and third chambers are separated from each other by a second separation wall, the second separation wall being in the tubular form of the garment Curved differently so as to extend in the longitudinal position around said second and third chambers, overlap in the longitudinal direction when the garment is in the form of the tubular or part tubular,
The first separation wall and the second separation wall have different curvatures;
The first separation wall has a greater curvature than the second separation wall, whereby the second chamber is larger than the overlap between the third chamber and the second chamber; An inflatable garment characterized in that an overlap is obtained with said first chamber.   2. The inflatable garment according to claim 1, wherein the first and second separation walls have a curved shape even when the garment is in a flat state.   The inflatable garment according to claim 1 or 2, wherein the first chamber has a curved wall on the opposite side of the first separation wall.   The inflatable garment according to any one of claims 1 to 3, wherein the third chamber has a curved wall on the opposite side of the second separation wall.   5. An inflatable garment according to any one of the preceding claims, wherein the inflating device has rounded or curved edges.   6. An inflatable garment according to claim 5, wherein the edge is an edge of the inflatable chamber.   7. An inflatable garment according to any one of the preceding claims, comprising a choke connecting adjacent chambers to each other, each specific or each choke having a predetermined dimension.   8. Inflatable garment according to claim 7, characterized in that the specific or each choke is in the form of a connecting tube.   9. An inflatable garment according to claim 7 or 8, wherein the inflating device comprises a plurality of chokes, the chokes having the same predetermined dimensions.   9. An inflatable garment according to claim 7 or 8, characterized in that the diameter of the choke is sized to make the expansion and contraction rates of adjacent chambers connected by the choke different.   10. An inflatable garment according to claim 7, 8 or 9, characterized in that the specific or each choke has a length of 40 mm and a bore diameter of 0.8 mm.   12. An inflatable garment according to any one of the preceding claims, comprising at least three chambers arranged in series.   13. An inflatable garment according to any one of the preceding claims, wherein the first chamber is larger than the second and other chambers.   14. An inflatable garment according to claim 13, wherein the second chamber is 70% of the volume of the first chamber.   15. The inflatable garment according to claim 14, wherein the specific or third chamber is 55% of the volume of the first chamber.   16. The inflatable garment according to any one of claims 1 to 15, comprising a contact member having a knitted or woven layer.   17. An inflatable garment according to any one of the preceding claims, wherein a cuff, sleeve, formed or conformable to fit around a portion of a patient's anatomy. Or a garment characterized by being another garment.

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